Evidence map›Paper›PMID 27951466›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2017

Clinical validation of a novel diagnostic HIV-2 total nucleic acid qualitative assay using the Abbott m2000 platform: Implications for complementary HIV-2 nucleic acid testing for the CDC 4th generation HIV diagnostic testing algorithm.

Ming Chang, Audrey J S Wong, Dana N Raugi, Robert A Smith, Annette M Seilie, Jose P Ortega, Kyle M Bogusz, Fatima Sall, Selly Ba, Moussa Seydi and 2 more

Abstract readValidation Study
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Detection and differentiation of HIV-2 using the point-of-care Alere q HIV-1/2 Detect nucleic acid test.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ming ChangDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Audrey J S WongDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Dana N RaugiDepartment of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, United States.
Robert A SmithDepartment of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, United States.
Annette M SeilieDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Jose P OrtegaDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Kyle M BoguszDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Fatima SallClinique des Maladies Infectieuses Ibrahima Diop Mar - CHNU de Fann, Universite Cheikh Anta Diop de Dakar, Senegal.
Selly BaClinique des Maladies Infectieuses Ibrahima Diop Mar - CHNU de Fann, Universite Cheikh Anta Diop de Dakar, Senegal.
Moussa SeydiClinique des Maladies Infectieuses Ibrahima Diop Mar - CHNU de Fann, Universite Cheikh Anta Diop de Dakar, Senegal.
Geoffrey S GottliebDepartment of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, United States; Department of Global Health, University of Washington, Seattle, United States.
Robert W CoombsDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States; Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, United States. Electronic address: bcoombs@u.washington.edu.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Improving Diagnosis, Treatment & Detection of Drug Resistance in HIV-2 InfectionR01AI120765 · NIAID · UNIVERSITY OF WASHINGTON · PI Geoffrey Scott Gottlieb · 2015 to 2026
$8.9M
Antiretroviral Therapy for HIV-2 Infection in SenegalR01AI060466 · NIAID · UNIVERSITY OF WASHINGTON · PI GOTTLIEB, GEOFFREY SCOTT · 2005 to 2014
$6.5M
NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI060466NIAID NIH HHS R01 AI120765NIAID NIH HHS U01 AI068618NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundThe 2014 CDC 4th generation HIV screening algorithm includes an orthogonal immunoassay to confirm and discriminate HIV-1 and HIV-2 antibodies. Additional nucleic acid testing (NAT) is recommended to resolve indeterminate or undifferentiated HIV seroreactivity. HIV-2 NAT requires a second-line assay to detect HIV-2 total nucleic acid (TNA) in patients' blood cells, as a third of untreated patients have undetectable plasma HIV-2 RNA.

objectivesTo validate a qualitative HIV-2 TNA assay using peripheral blood mononuclear cells (PBMC) from HIV-2-infected Senegalese study participants. STUDY

designWe evaluated the assay precision, sensitivity, specificity, and diagnostic performance of an HIV-2 TNA assay. Matched plasma and PBMC samples were collected from 25 HIV-1, 30 HIV-2, 8 HIV-1/-2 dual-seropositive and 25 HIV seronegative individuals. Diagnostic performance was evaluated by comparing the outcome of the TNA assay to the results obtained by the 4th generation HIV screening and confirmatory immunoassays.

resultsAll PBMC from 30 HIV-2 seropositive participants tested positive for HIV-2 TNA including 23 patients with undetectable plasma RNA. Of the 30 matched plasma specimens, one was HIV non-reactive. Samples from 50 non-HIV-2 infected individuals were confirmed as non-reactive for HIV-2 Ab and negative for HIV-2 TNA. The agreement between HIV-2 TNA and the combined immunoassay results was 98.8% (79/80). Furthermore, HIV-2 TNA was detected in 7 of 8 PBMC specimens from HIV-1/HIV-2 dual-seropositive participants.

conclusionsOur TNA assay detected HIV-2 DNA/RNA in PBMC from serologically HIV-2 reactive, HIV indeterminate or HIV undifferentiated individuals with undetectable plasma RNA, and is suitable for confirming HIV-2 infection in the HIV testing algorithm.

Indexed as

AlgorithmsCenters for Disease Control and Prevention, U.S.DNA, ViralHIV-2HIV InfectionsHumansLeukocytes, MononuclearMolecular Diagnostic TechniquesRNA, ViralSensitivity and SpecificityUnited StatesDNA, ViralRNA, ViralDiagnosticDNA/RNAHIV-2PCRQualitativeTotal nucleic acid

Identifiers

PMID27951466
PMCPMC5218592

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.